The present invention relates generally to medical apparatus and methods and more particularly to devices and methods for the insertion and securing of expandable devices and the like into a patient's body cavity, such as the stomach, intestine or gastrointestinal track for purposes of taking up space to provide the patient with a feeling of satiety or fullness. These devices may also be removed once they have served their purpose, e.g., the patient has lost the directed or desired amount of weight.
Currently, in cases of severe obesity, patients may undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the intestinal track. Procedures such as laparoscopic banding, where a device is used to “tie off” or constrict a portion of the stomach, or the placement of intragastric balloons can also achieve these results.
Endoscopic procedures that have been used to assist weight loss have been primarily focused on the placement of a balloon or other space occupying device in the patient's stomach to fill portions of the stomach to provide the patient with the feeling of fullness, thereby reducing food intake. To accomplish these procedures, an endoscope is utilized to guide the balloon through the patient's mouth and down the esophagus to the stomach. Usually these procedures have allowed placement of the device for 6-12 months, and are coupled with counseling and other types of psychological support.
In the case of laparoscopic banding or balloon placement, however, several complications can arise that make these procedures, in their present form, clinically suboptimal. The surgical interventions described above require the patient to submit to an intervention under general anesthesia, and can require large incisions and lengthy recovery time. The less invasive procedures described above, although clinically efficacious in many cases, suffer from complications ranging from deflation of the devices resulting in unsustained weight loss, stomach erosion, bowel obstruction and even death.
Many of these described problems have stemmed from the fact that the devices were not robust enough to sustain long term implantation, and that they were implanted in such a manner as to remain unattached or free-floating within the stomach. Further, due to the caustic nature of stomach acids and other factors, many of the implants deflated and migrated into the intestine, causing bowel obstructions and in some cases death. Also, many devices were not well designed for removal, leading to additional technical difficulties for the clinician.
Additionally, current balloon designs do not allow for the adjustment of balloon size, days or months after initial implantation. This feature would be useful to adjust performance and/or reliability, which may be useful over time.
Because of the limited success of several of these procedures, there remains a need for improved devices and methods for more effective, less invasive, weight loss.